"The U.S. Food and Drug Administration announced today that injectable drugs used in total parenteral nutrition (TPN) in critical shortage will be imported into the United States and available to patients this week.
TPN is an intravenous"...
0.5 mmol/mL(gadoversetamide) Injection
For Intravenous Injection Only
NEPHROGENIC SYSTEMIC FIBROSIS
Gadolinium-based contrast agents (GBCAs) increase the risk for NSF among patients with impaired elimination of the drugs. Avoid use of GBCAs in these patients unless the diagnostic information is essential and not available with non-contrasted MRI or other modalities. NSF may result in fatal or debilitating fibrosis affecting the skin,muscle and internal organs.
- Do not administer OptiMARK™ to
- chronic, severe kidney disease (GFR < 30 mL/min/1.73m²), or
- acute kidney injury (see CONTRAINDICATIONS).
- Screen patients for acute kidney injury and other conditions that may reduce renalfunction. For patients at risk for chronically reduced renal function (e.g. age > 60 years, hypertension or diabetes), estimate the glomerular filtration rate (GFR)through laboratory testing.
- Do not exceed the recommended OptiMARK™ dose and allow a sufficient period oftime for elimination of the drug from the body prior to any re-administration (see WARNINGS).
OptiMARK™ (gadoversetamide injection) is a formulation of a nonionic gadolinium chelate of diethylenetriamine pentaacetic acid bismethoxyethylamide (gadoversetamide), for use in magnetic resonance imaging (MRI). OptiMARK™ Injection is to be administered by intravenous injection only.
OptiMARK™ Injection is provided as a sterile, nonpyrogenic, clear, colorless to pale yellow, aqueous solution of gadoversetamide. No preservative is added. Each mL of OptiMARK™ Injection contains 330.9 mg of gadoversetamide (0.5 millimole), 28.4 mg of calcium versetamide sodium (0.05 millimole), 0.7 mg calcium chloride dihydrate (0.005 millimole), and water for injection. Sodium hydroxide and/or hydrochloric acid may have been added for pH adjustment.
OptiMARK™ Injection is designated chemically as [8, 11-bis(carboxymethyl)-14-[2-[(2methoxyethyl)amino]-2-oxoethyl]-6-oxo-2-oxa-5,8,11,14-tetraazahexadecan-16-oato(3-)] gadolinium with a formula weight of 661.77 g/mol and empirical formula of C20H34N5O10Gd. The structural formula of gadoversetamide in aqueous solution is:
OptiMARK™ Injection has a pH of 5.5 to 7.5 and pertinent physiochemical data are provided below:
Table 1: Physiochemical Data
|Osmolality (mOsmol/kg water) @ 37°C||1110|
|Density (g/mL) @ 25°C||1.16|
OptiMARK™ Injection has an osmolality of approximately 3.9 times that of plasma (285 mOsm/kg water) and is hypertonic under conditions of use.
Last reviewed on RxList: 9/9/2013
This monograph has been modified to include the generic and brand name in many instances.
Additional OptiMARK Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Find out what women really need.